CN115886783A - Shape sensing reference frame - Google Patents

Abstract

A system and method for detecting placement of a medical device within a patient is disclosed herein, wherein the system includes a medical device comprising an optical fiber having a core fiber. Each of the one or more core fibers includes a plurality of sensors that may be configured to reflect optical signals having altered characteristics due to strain experienced by the optical fiber. The system also includes logic that may be configured to determine a 3D shape of the medical device from the strain of the optical fiber. The logic may also be configured to (i) define a frame of reference for the 3D shape and (ii) render an image of the 3D shape on a display of the system according to the frame of reference.

Description

Shape sensing reference frame

Priority

This application claims priority from U.S. provisional application No. 63/250,727, filed on 30/9/2021, which is incorporated herein by reference in its entirety.

Technical Field

The present application relates to the field of medical instruments, and more particularly to a shape sensing reference frame.

Background

In the past, certain intravascular guides for medical devices (such as guidewires and catheters), for example, have used fluoroscopy methods to track the tip of the medical device and determine whether the distal tip is properly positioned in its target anatomy. However, such fluoroscopy methods expose patients and their attending physicians to harmful X-ray radiation. Furthermore, in some cases, the patient is exposed to potentially harmful contrast agents required for fluoroscopy methods.

A fiber optic shape sensing system and method performed thereby are disclosed herein, wherein the system is configured to display an image of a three-dimensional shape of a medical device using fiber optic technology. Further, the system is configured to define a frame of reference for the three-dimensional shape to enable a clinician to view an image of the three-dimensional shape according to a defined orientation of the three-dimensional shape.

Disclosure of Invention

Briefly, disclosed herein is a medical device system for detecting placement of a medical device within a patient. The system includes a medical device including an optical fiber having one or more core fibers, each of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of the respective core fiber, and each of the plurality of sensors being configured to (i) reflect an optical signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected optical signal based on a strain experienced by the optical fiber. The system also includes a console including one or more processors and a non-transitory computer-readable medium having logic stored thereon that, when executed by the one or more processors, causes operation of the system. The operations include (i) providing an incident light signal to the optical fiber, (ii) receiving reflected light signals of different spectral widths of the incident light reflected by one or more of the plurality of sensors, (iii) processing the reflected light signals associated with the one or more core fibers to determine a three-dimensional (3D) shape of the optical fiber, (iv) defining a reference frame for displaying an image of the 3D shape, (v) orienting the 3D shape within the reference frame, and (vi) rendering the image of the 3D shape on a display of the system according to the reference frame.

In some embodiments, orienting the 3D shape includes defining a reference plane from a portion of the 3D shape, securing the 3D shape to the reference plane, and orienting the reference plane relative to a reference frame. The portion of the 3D shape may include three or more points arranged along the 3D shape, and the three or more points may be equidistant from the reference plane.

The system may further include a guide having a lumen extending along a linear portion of the guide, wherein, in use, the optical fiber is inserted into the lumen, and the operations further include aligning the optical fiber according to the linear portion. In some embodiments, the guide is inserted into the patient.

The operations may further include orienting the reference plane relative to a reference frame such that the elevation image according to the 3D shape of the reference frame is aligned with an elevation of the patient, and fixing the reference plane relative to the reference frame.

In some embodiments, the operations further comprise comparing the curved portion of the 3D shape to a curved shape stored in the memory, and as a result of the comparison, identifying three or more points from the curved portion to define a reference plane when the curved portion of the 3D shape conforms to the curved shape stored in the memory. In use, the 3D shaped curved portion may be disposed along a basilic vein, a subclavian vein, a innominate vein, or a superior vena cava of the patient.

The system may include a plurality of curved shapes stored in the memory associated with a plurality of different insertion sites of the medical device, and the operations may further include (i) receiving input from a clinician defining an insertion site of the medical device, (ii) selecting a curved shape from the plurality of curved shapes, the selected curved shape associated with the defined insertion site, and (iii) comparing the curved portion of the 3D shape to the selected curved shape. The clinician's input may also define the insertion site as being located on the right or left side of the patient.

The system may also include a reference guide coupled with the medical device, wherein the curved portion of the 3D shape is disposed along a path of the reference guide, and an orientation of the reference guide relative to the patient defines an orientation of the 3D shape relative to the patient. In use, the reference guide may be displaced relative to the patient between a first guide orientation and a second guide orientation to move the 3D shape relative to the patient between the first 3D shape orientation and the second 3D shape orientation.

The system may be coupled with a patient imaging system, and the operations may further include receiving image data from the imaging system and presenting an image of the patient and an image of the 3D shape on a display.

The medical device may be one of an introducer wire, a guidewire, a stylet within a needle, a needle having an optical fiber embedded in a cannula of the needle, or a catheter having an optical fiber embedded in one or more walls of the catheter.

Also disclosed herein is a method for detecting placement of a medical device within a patient. The method includes providing an optical fiber included within a medical device with an incident optical signal, wherein the optical fiber includes one or more core fibers, each of the one or more core fibers includes a plurality of reflection gratings distributed along a longitudinal length of the respective core fiber, and each of the plurality of reflection gratings is configured to (i) reflect an optical signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected optical signal based on a strain experienced by the optical fiber. The method also includes (i) receiving reflected light signals of different spectral widths of incident light reflected by one or more of the plurality of sensors, (ii) processing the reflected light signals associated with the one or more core fibers to determine a three-dimensional (3D) shape of the optical fiber, (iii) defining a reference frame for displaying an image of the 3D shape, (iv) orienting the 3D shape within the reference frame, and (v) rendering the image of the 3D shape on a display of the system according to the reference frame.

In some embodiments of the method, orienting the 3D shape includes defining a reference plane from a portion of the 3D shape, securing the 3D shape to the reference plane, and orienting the reference plane relative to a reference frame. The portion of the 3D shape may include three or more points arranged along the 3D shape, and the three or more points may be equidistant from the reference plane.

In some embodiments of the method, the system includes a guide having a lumen extending along a straight portion of the guide, and in use, the optical fiber is inserted into the lumen. The method also includes aligning the optical fiber with respect to the straight portion. The guide may be inserted into a patient.

The method may further include (i) orienting the reference plane relative to a reference frame such that the elevation image according to the 3D shape of the reference frame is aligned with an elevation of the patient, and (ii) fixing the reference plane relative to the reference frame.

In some embodiments, the method further includes comparing the curved portion of the 3D shape to a curved shape stored in a memory of the system, and as a result of the comparison, identifying three or more points from the curved portion to define the reference plane when the curved portion of the 3D shape conforms to the curved shape stored in the memory.

In some embodiments of the method, the 3D shaped curved portion is disposed along a basilic vein, a subclavian vein, a innominate vein, or a superior vena cava of the patient. In some embodiments of the method, the system includes a plurality of curved shapes stored in the memory associated with a plurality of different insertion sites, the method further comprising (i) receiving input from the clinician defining an insertion site for the medical device, (ii) selecting a curved shape from the plurality of curved shapes, the selected curved shape associated with the defined insertion site, and (iii) comparing the curved portion of the 3D shape to the selected curved shape. The clinician's input may also define the insertion site as being located on the right or left side of the patient.

In some embodiments of the method, (i) the system includes a reference guide coupled with the medical device, (ii) the curved portion of the 3D shape is disposed along a path of the reference guide, and (iii) an orientation of the reference guide relative to the patient defines an orientation of the 3D shape relative to the patient.

The method may also include displacing the reference guide relative to the patient between the first guide orientation and the second guide orientation to move the 3D shape relative to the patient between the first 3D shape orientation and the second 3D shape orientation.

In some embodiments of the method, the system is coupled with a patient imaging system, and the method further comprises receiving image data from the imaging system and presenting an image of the patient and an image of the 3D shape on a display.

These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the drawings and the following description that disclose in greater detail specific embodiments of these concepts.

Drawings

Embodiments of the disclosure are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

fig. 1A is an illustrative embodiment of a medical device monitoring system including a medical device with optical shape sensing and fiber-based oximetry capabilities, in accordance with some embodiments;

fig. 1B is an alternative illustrative embodiment of a medical device monitoring system 100 according to some embodiments;

FIG. 2 is an exemplary embodiment of a structure of a portion of a multicore optical fiber included within the stylet 120 of FIG. 1A, according to some embodiments;

fig. 3A is a first exemplary embodiment of the stylet of fig. 1A, which supports both optical and electrical signaling (signaling), in accordance with some embodiments;

fig. 3B is a cross-sectional view of the stylet of fig. 3A, according to some embodiments;

fig. 4A is a second exemplary embodiment of the stylet of fig. 1B, according to some embodiments;

figure 4B is a cross-sectional view of the stylet of figure 4A, according to some embodiments;

fig. 5A is a front view of a first illustrative embodiment of a catheter including an integrated tubing (integrated tubing), a septum disposed along a diameter (diametrically), and a micro-lumen within the tubing and the septum, according to some embodiments;

fig. 5B is a perspective view of a first illustrative embodiment of the catheter of fig. 5A including a core fiber mounted within a micro lumen, in accordance with some embodiments;

fig. 6A-6B are flow diagrams of operational methods implemented by the medical instrument monitoring system of fig. 1A-1B to implement optical 3D shape sensing, according to some embodiments;

fig. 7A is an exemplary embodiment of the medical device monitoring system of fig. 1A-1B during catheter operation and insertion into a patient, according to some embodiments;

FIG. 7B illustrates the 3D shape of FIG. 7A according to a frame of reference according to some embodiments;

fig. 8 is an exemplary screen shot of the 3D shaped image of fig. 7A and 7B, according to some embodiments;

fig. 9 is a flow diagram of a method of operation performed by the medical instrument monitoring system of fig. 1A-1B to display an image of a 3D shape according to a frame of reference, according to some embodiments; and

fig. 10 illustrates an embodiment of a reference guide for defining the frame of reference of fig. 7A and 7B, according to some embodiments.

Detailed Description

Before some particular embodiments are disclosed in more detail, it is to be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that particular embodiments disclosed herein may have features that can be readily separated from the particular embodiments, and optionally combined with or substituted for the features of any of the numerous other embodiments disclosed herein.

With respect to the terminology used herein, it is also to be understood that the terminology is for the purpose of describing particular embodiments, and that the terminology is not intended to limit the scope of the concepts provided herein. Ordinals (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not provide a serial or numerical limitation. For example, "first," "second," "third" features or steps need not necessarily occur in sequence, and particular embodiments that include such features or steps need not necessarily be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back", and the like are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such indicia are used to reflect, for example, relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

Reference to a "proximal," "proximal portion," or "proximal end portion" of a probe, such as disclosed herein, includes the portion of the probe that is intended to be near the clinician when the probe is used on a patient. Likewise, for example, the "proximal length" of the probe includes the length of the probe that is expected to be near the clinician when the probe is used with a patient. For example, when the probe is used on a patient, the "proximal end" of the probe includes the end of the probe that is proximal to the clinician. The proximal portion, proximal end portion, or proximal length of the probe may comprise the proximal end of the probe; however, the proximal portion, or proximal length of the probe need not comprise the proximal end of the probe. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the probe is not the distal portion or end length of the probe.

For example, a "distal", "distal portion", or "distal portion" of a probe disclosed herein includes a portion of the probe that is intended to be near or in a patient when the probe is used in the patient. Likewise, for example, the "distal length" of the probe includes the length of the probe that is expected to be near or in the patient when the probe is used with the patient. For example, when the probe is used with a patient, the "distal end" of the probe includes the end of the probe that is near or within the patient. The distal portion, or distal length of the probe may comprise the distal end of the probe; however, the distal portion, or length of the distal end of the probe need not include the distal end of the probe. That is, unless the context indicates otherwise, the distal portion, or length of the distal end of the probe is not the tip portion or length of the tip of the probe.

The term "logic" may represent hardware, firmware, or software configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and/or storage functionality. Examples of such circuitry may include, but are not limited to, a hardware processor (e.g., a microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit "ASIC," etc.), a semiconductor memory, or a combination of elements.

Additionally or in the alternative, the term logic may refer to or include software, such as one or more processes, one or more instances, application Programming Interfaces (APIs), subroutines, functions, applets, servlets, routines, source code, object code, shared libraries/dynamic link libraries (dlls), or even one or more instructions. The software may be stored in any type of suitable non-transitory storage medium or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals, such as carrier waves, infrared signals, or digital signals). Examples of non-transitory storage media may include, but are not limited to or limited to, programmable circuitry; non-persistent memory, such as volatile memory (e.g., any type of random access memory "RAM"); or persistent storage such as non-volatile memory (e.g., read-only memory "ROM", power-supplied RAM, flash memory, phase-change memory, etc.), a solid-state drive, a hard-disk drive, an optical-disk drive, or a portable memory device. As firmware, logic may be stored in persistent storage.

Any method disclosed herein comprises one or more steps or actions for performing the method. Method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, only a portion of the subroutines or methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only a portion of the steps described in the more detailed methods.

The phrases "connected to" and "coupled to" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluidic, and thermal interactions. The two components may be connected or coupled to each other even if not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

Referring to fig. 1A, an illustrative embodiment of a medical device monitoring system including a medical device with optical shape sensing and fiber-based oximetry capabilities is shown in accordance with some embodiments. As shown, the system 100 generally includes a console 110 and a stylet assembly 119 communicatively coupled to the console 110. For this embodiment, the stylet assembly 119 includes an elongate stylet (e.g., stylet) 120 at its distal end 122 and a console connector 133 at its proximal end 124. The console connector 133 enables the stylet assembly 119 to be operatively connected to the console 110 via an interconnect 145 that includes one or more optical fibers 147 (hereinafter "optical fibers") and a conductive medium terminated by a single optical/electrical connector 146 (or terminated by a dual connector). Here, the connector 146 is configured to engage (mate) with the console connector 133 to allow light to propagate between the console 110 and the stylet assembly 119 and electrical signals to propagate from the stylet 120 to the console 110.

The exemplary embodiment of console 110 includes a processor 160, a memory 165, a display 170, and optical logic 180, although it is understood that console 110 may take one of a variety of forms and may include additional components (e.g., power supplies, ports, interfaces, etc.) not related to aspects of the disclosure. An illustrative embodiment of the console 110 is shown in U.S. patent No. 10,992,078, which is incorporated herein by reference in its entirety. Including a processor 160 that can access memory 165 (e.g., non-volatile memory or a non-transitory computer-readable medium) to control the functions of console 110 during operation. As shown, the display 170 may be a Liquid Crystal Diode (LCD) display integrated into the console 110 and used as a user interface to display information to the clinician, particularly during a catheter placement procedure (e.g., cardiac catheterization). In another embodiment, the display 170 may be separate from the console 110. Although not shown, the user interface is configured to provide user control of the console 110.

For both embodiments, the content depicted by the display 170 may change depending on the mode (optical, TLS, ECG, or another modality) in which the stylet 120 is configured to operate. In the TLS mode, the content presented by the display 170 may constitute a two-dimensional (2D) or three-dimensional (3D) representation of the stylet 120's physical state (e.g., length, shape, form, and/or orientation), as calculated from the characteristics of the reflected light signal 150 returning to the console 110. Reflected light signal 150 constitutes a particular spectral width of light of broadband incident light 155 that is reflected back to console 110. According to one embodiment of the disclosure, reflected light signal 150 may involve various discrete portions (e.g., particular spectral widths) of broadband incident light 155 delivered from optical logic 180 and originating from optical logic 180, as described below.

According to one embodiment of the disclosure, the activation control 126 included on the stylet assembly 119 can be used to place the stylet 120 in a desired mode of operation, and to selectively change the operability of the display 170 by the clinician to assist in medical device placement. For example, based on the modality of the stylet 120, the display 170 of the console 110 can be used for optical modality-based guidance during advancement of the catheter through the vasculature or during the TLS modality to determine the physical state (e.g., length, form, shape, orientation, etc.) of the stylet 120. In one embodiment, information from multiple modes, such as optical, TLS, or ECG, for example, may be displayed simultaneously (e.g., at least partially overlapping in time).

Still referring to fig. 1A, optical logic 180 is configured to support operability of stylet assembly 119 and enable information to be returned to console 110, which can be used to determine physical conditions associated with stylet 120 and monitored electrical signals, such as ECG signaling via electrical signaling logic 181, with electrical signaling logic 181 supporting receiving and processing of received electrical signals from stylet 120 (e.g., ports, analog-to-digital conversion logic, etc.). The physical state of the stylet 120 can vary based on the characteristics of the reflected light signal 150 received at the console 110 from the stylet 120. The characteristic may include something comprised of a core fiber integrated within fiber core 135 located within stylet 120 or operating as stylet 120The strain induced wavelength shift on these regions is shown below. As discussed herein, the optical fiber core 135 may include a core fiber 137 ₁ To 137 _M (for a single core, M =1, for multiple cores, M ≧ 2), wherein core fiber 137 ₁ To 137 _M May be collectively referred to as core fiber(s) 137. Unless otherwise stated or this embodiment requires an alternate explanation, the embodiments discussed herein will refer to a multicore fiber 135. From the information associated with the reflected light signal 150, the console 110 can determine (by calculation or extrapolation of the wavelength offset) the physical state of the stylet 120 and the physical state of the catheter 121 configured to receive the stylet 120.

According to one embodiment of the disclosure, as shown in fig. 1A, optical logic 180 may include an optical source 182 and an optical receiver 184. The light source 182 is configured to deliver incident light 155 (e.g., broadband) for propagation over the optical fiber(s) 147 included in the interconnect 145, the optical fibers 147 being optically connected to the multicore fiber core 135 within the stylet 120. In one embodiment, the light source 182 is a tunable swept-frequency laser, but other suitable light sources besides lasers may be employed, including semi-coherent light sources, LED light sources, and the like.

The optical receiver 184 is configured to: (i) Receiving a returned optical signal, i.e., a reflected optical signal 150 received from a fiber-based reflection grating (sensor) fabricated within each core fiber of a multi-core fiber 135 disposed within a stylet 120; and (ii) converting the reflected light signal 150 into reflection data (from the repository 192), i.e., data in the form of an electrical signal representative of the reflected light signal that includes the wavelength shift caused by the strain. The reflected optical signals 150 associated with different spectral widths may include reflected optical signals 151 provided from sensors located in a central core fiber (reference) of the multi-core optical fiber 135 and reflected optical signals 152 provided from sensors located in peripheral core fibers of the multi-core optical fiber 135, as described below. Here, the optical receiver 184 may be implemented as a photodetector, such as a positive-intrinsic-negative "PIN" photodiode, an avalanche photodiode, or the like.

As shown, both the light source 182 and the optical receiver 184 are operatively connected to the processor 160 that manages their operation. In addition, the optical receiver 184 is operably coupled to provide the reflection data (from the repository 192) to the memory 165 for storage and processing by the reflection data sorting logic 190. The reflection data classification logic 190 may be configured to: (i) Identifying which core fibers are relevant to which of the received reflection data (from repository 192); and (ii) dividing the reflectance data (provided by the reflected light signal 150 associated with a similar region or spectral width of the stylet 120) stored with the repository 192 into analysis groups. The reflection data for each analysis group is available to the shape sensing logic 194 for analysis.

According to one embodiment of the disclosure, the shape sensing logic 194 is configured to compare the wavelength shift measured by the sensor in each peripheral core fiber deployed at the same measurement region (or same spectral width) of the stylet 120 with the wavelength shift at the central core fiber of the multi-core optical fiber 135 positioned along the central axis and operating as a bend neutral axis. From these analyses, shape sensing logic 194 may determine the shape assumed by the core fiber in 3D space, and may further determine the current physical state of catheter 121 in 3D space for presentation on display 170.

According to one embodiment of the disclosure, the shape sensing logic 194 may generate a presentation of the current physical state of the stylet 120 (and potentially the catheter 121) based on heuristics or runtime analysis. For example, the shape sensing logic 194 may be configured according to machine learning techniques to access a data store (library) having pre-stored data (e.g., images, etc.) relating to different regions of the stylet 120 (or catheter 121) in which reflected light from the core fiber has previously experienced similar or identical wavelength shifts. From the pre-stored data, the current physical state of the stylet 120 (or catheter 121) can be presented. Alternatively as another embodiment, the shape sensing logic 194 may be configured to determine a change in the physical state of each region of the multi-core fiber 135 during runtime based on at least: (i) The resultant (residual) wavelength shift experienced by the different core fibers within the optical fiber 135; and (ii) the relationship between these wavelength shifts generated by sensors positioned along different peripheral core fibers at the same cross-sectional area of the multi-core optical fiber 135 and the wavelength shift generated by a sensor of the central core fiber at the same cross-sectional area. It is contemplated that other procedures and procedures may be performed to present appropriate changes in the physical state of the stylet 120 (and/or catheter 121) with wavelength shifts measured by sensors along each core fiber within the multi-core optical fiber 135, particularly when the stylet 120 is positioned at the distal tip of the catheter 121, to enable guidance of the stylet 120 within the vasculature of the patient and at the desired destination within the body.

The console 110 can further include electrical signaling logic 181 positioned to receive one or more electrical signals from the stylet 120. The stylet 120 is configured to support both optical and electrical connectivity. The electrical signaling logic 181 receives electrical signals (e.g., ECG signals) from the stylet 120 via a conductive medium. The electrical signals may be processed by electrical signal logic 196 for execution by processor 160 to determine an ECG waveform for display.

Referring to fig. 1B, an alternative exemplary embodiment of a medical instrument monitoring system 100 is shown. Here, the medical instrument monitoring system 100 features a console 110 and a medical instrument 130 communicatively coupled to the console 110. For this embodiment, the medical device 130 corresponds to a catheter characterized by an integrated tubing having two or more lumens extending between a proximal end 131 and a distal end 132 of the integrated tubing. The integrated tubing (sometimes referred to as "catheter tubing") communicates with one or more extension legs 140 via a furcation insert 142. An optical-based catheter connector 144 may be included on a proximal end of the at least one extension leg 140 to enable the catheter 130 to be operably connected to the console 110 via an interconnect 145 or another suitable component. Here, the interconnect 145 can include a connector 146, which when coupled to the optical-based catheter connector 144, the connector 146 establishes optical connectivity between one or more optical fibers 147 (hereinafter, "optical fiber(s)") included as part of the interconnect 145 and the core fiber 137 deployed within the catheter 130 and integrated into the tubing. Alternatively, the optical fiber(s) 147 may be optically connected to the core fiber 137 within the catheter 130 using different combinations of connectors including one or more adapters. The core fiber 137 deployed within the catheter 130 as shown in fig. 1B includes the same characteristics and performs the same functions as the core fiber 137 deployed within the stylet 120 of fig. 1A.

Optical logic 180 is configured to support graphical rendering of catheter 130 (most notably, the integral tubing of catheter 130) based on characteristics of reflected optical signal 150 received from catheter 130. The characteristics may include wavelength shifts caused by strain on certain areas of the core fiber 137 integrated within (or along) the wall of the integrated tubing, which may be used to determine (by calculation or extrapolation of the wavelength shifts) the physical state of the catheter 130, particularly the integrated tubing or a portion of the integrated tubing (such as the tip or distal end).

More specifically, optical logic 180 includes a light source 182. The light source 182 is configured to transmit broadband incident light 155 for propagation over the optical fiber(s) 147 included in the interconnect 145, the optical fibers 147 being optically connected to the plurality of core fibers 137 within the catheter tubing. Here, the optical receiver 184 is configured to: (i) Receiving the returned optical signals, i.e., the reflected optical signals 150 received from the fiber-based reflection gratings (sensors) fabricated within each of the core fibers 137 disposed within the conduit 130; and (ii) converting the reflected light signal 150 into reflection data (from the repository 192), i.e., data in the form of an electrical signal representative of the reflected light signal, which includes a wavelength shift caused by strain. Reflected light signals 150 associated with different spectral widths include reflected light signal 151 provided from a sensor located in a center core fiber (reference) of conduit 130 and reflected light signal 152 provided from a sensor located in an outer core fiber of conduit 130, as described below.

As described above, the shape sensing logic 194 is configured to compare the wavelength shift measured by the sensors disposed in each outer core fiber at the same measurement region (or same spectral width) of the catheter to the wavelength shift at the center core fiber positioned along the center axis and operating as the bend neutral axis. From these analyses, shape sensing logic 190 may determine the shape assumed by the core fiber in 3D space, and may further determine the current physical state of catheter 130 in 3D space for presentation on display 170.

According to one embodiment of the disclosure, the shape sensing logic 194 may generate a representation of the current physical state of the catheter 130 (particularly the integrated tubing) based on heuristics or runtime analysis. For example, the shape sensing logic 194 may be configured to access a data store (library) having pre-stored data (e.g., images, etc.) relating to different regions of the catheter 130 in which the core fiber 137 is subject to similar or identical wavelength shifts in accordance with machine learning techniques. From the pre-stored data, the current physical state of catheter 130 may be presented. Alternatively, as another embodiment, shape sensing logic 194 may be configured to determine a change in the physical state of each region of catheter 130 during runtime based at least on: (ii) the resultant wavelength shift experienced by the core fiber 137; and (ii) the relationship between these wavelength shifts produced by sensors positioned along different outer core fibers at the same cross-sectional area of catheter 130 and the wavelength shift produced by a sensor of the central core fiber at the same cross-sectional area. It is contemplated that other processes and procedures may be performed to present an appropriate change in the physical state of the catheter 130 with the wavelength shift measured by the sensors along each core fiber 137.

Referring to fig. 2, an exemplary embodiment of a structure of a portion of a multicore fiber included within the stylet 120 of fig. 1A is shown, according to some embodiments. Multicore fiber portion 200 of multicore fiber 135 shows some of the core fibers 137 ₁ To 137 _M (M.gtoreq.2, as shown in FIG. 3A, M = 4), and are present in the core fiber 137, respectively ₁ To 137 _M Internal sensor (e.g., reflective grating) 210 ₁₁ To 210 _NM (N.gtoreq.2 and M.gtoreq.2) in the space relationship. As described above, the core fiber 137 may be formed ₁ To 137 _M Collectively referred to as "core fiber 137".

As shown, portion 200 is divided into a plurality of cross-sectional areas 220 ₁ To 220 _N Wherein each cross-sectional area 220 ₁ To 220 _N Corresponding to the reflection grating 210 ₁₁ To 210 ₁₄ …210 _N1 To 210 _N4 . Cross sectional area 220 ₁ …220 _N May be static (e.g., a specified length) or may be dynamic (e.g., in region 220) ₁ …220 _N Of varying size). First core fiber 137 ₁ Substantially along a central (neutral) axis 230, and a core fiber 137 ₂ May be oriented within the cladding of the multi-core fiber 135, as viewed from a cross-sectional front-facing perspective, at the first core fiber 137 ₁ On the "top" of (c). In this deployment, the core fiber 137 ₃ And 137 ₄ May be located in the first core fiber 137 ₁ The "lower left portion" and the "lower right portion" of (c). By way of example, fig. 3A-4B provide such an illustration.

Reference to a first core fiber 137 ₁ As an illustrative embodiment, when the stylet 120 is operational, the reflective grating 210 ₁ To 210 _N Each reflecting light of a different spectral width. As shown, according to one embodiment of the disclosure, a grating 210 _1i To 210 _Ni (1 ≦ i ≦ M) each associated with a different specific spectral width, which will be defined by a different center frequency f ₁ …f _N Indicating that adjacent spectral widths reflected by adjacent gratings do not overlap.

Here, the different core fibers 137 ₂ To 137 ₃ But along the same cross-sectional area 220 to 220 of the multi-core fiber 135 _N A grating 210 ₁₂ To 210 _N2 And 210 ₁₃ To 210 _N3 Configured to reflect incident light at the same (or substantially similar) center frequency. As a result, the reflected light returns information that allows the physical state of the fiber 137 (and stylet 120) to be determined based on the wavelength shift measured from the returned reflected light. Specifically, to multicore optical fiber 135 (e.g., at least core fiber 137) ₂ To 137 ₃ ) Strain (e.g. compression or tension) of (a) causes reversal ofThe wavelength shift associated with the impinging light. Based on different positions, core fiber 137 ₁ To 137 ₄ Subject to different types and degrees of strain (based on angular path changes as the stylet 120 advances in the patient).

For example, relative to the multicore fiber portion 200 of fig. 2, in response to the angular motion (e.g., radial motion) of the stylet 120 being in the left steering direction, the fourth core fiber 137 of the multicore fiber 135 having the shortest radius during movement ₄ (see fig. 3A) (e.g., the core fiber closest to the direction of the angle change) will exhibit compression (e.g., a force that shortens the length). At the same time, the third core fiber 137 having the longest radius during the movement ₃ (e.g., the core fiber furthest from the direction of angular change) will exhibit stretch (e.g., a force of increasing length). Since these forces are different and unequal, they come from the core fiber 137 ₂ And 137 ₃ Associated reflection grating 210 _N2 And 210 _N3 Will exhibit different wavelength variations. By being directed with respect to a reference core fiber (e.g., the first core fiber 137) located along the neutral axis 230 of the multi-core optical fiber 135 ₁ ) Determines each peripheral optical fiber (e.g., second core fiber 137) ₂ And a third core fiber 137 ₃ ) The degree of wavelength change caused by compression/tension, the difference in wavelength shift of the reflected light signal 150 may be used to extrapolate the physical configuration of the stylet 120. These degrees of wavelength change can be used to extrapolate the physical state of the stylet 120. Reflected optical signal 150 via a particular core fiber 137 ₁ To 137 _M The separate path above is reflected back to the console 110.

Referring to fig. 3A, a first exemplary embodiment of the stylet of fig. 1A is shown, supporting both optical and electrical signaling, according to some embodiments. Here, the stylet 120 features a centrally located multi-core fiber 135 that includes a cladding 300 and a plurality of corresponding lumens 320 ₁ To 320 _M Inner plurality of core fibers 137 ₁ To 137 _M (M.gtoreq.2. Although in four (4) core fibers 137 ₁ To 137 ₄ Multiple core fibers 135 are illustrated, but a greater number of core fibers 137 may be deployed ₁ To 137 _M (M＞4) To provide more detailed 3D sensing of the physical state (e.g., shape, etc.) of the stylet 120 and the multicore fiber 135 in which the fiber 135 is deployed.

For this embodiment of the disclosure, the multicore fibers 135 are encapsulated within a concentric braided tube 310 over a low coefficient of friction layer 335. The braided tubing 310 may feature a "mesh" configuration, wherein the spacing between crossing conductive elements is selected based on the degree of rigidity desired for the stylet 120, as a larger spacing may provide less rigidity, and thus a more flexible stylet 120.

According to this embodiment of the disclosure, as shown in fig. 3A-3B, a core fiber 137 ₁ To 137 ₄ Comprising (i) a central core fiber 137 ₁ And (ii) a plurality of peripheral core fibers 137 ₂ To 137 ₄ Which is retained within a lumen 320 formed in the cladding 300 ₁ To 320 ₄ And (4) the following steps. According to one embodiment of the disclosure, inner chamber 320 ₁ To 320 ₄ May be configured to be larger in size than the core fiber 137 ₁ To 137 ₄ Of (c) is measured. By avoiding core fibres 137 ₁ To 137 ₄ Most of the surface area and lumen 320 ₁ To 320 ₄ Is in direct physical contact with the wall surface, the wavelength variation of the incident light caused by the angular deviation in the multi-core fiber 135 is reduced, thereby reducing the light applied to the inner cavity 320 ₁ To 320 _M Wall (rather than core fiber 137) ₁ To 137 _M Itself) of the pressure and tension.

As further shown in FIGS. 3A-3B, core fiber 137 ₁ To 137 ₄ May include a first lumen 320 formed along the first neutral axis 230 ₁ Inner central core fiber 137 ₁ And in the inner cavity 320 ₂ To 320 ₄ Inner plurality of core fibers 137 ₂ To 137 ₄ (each formed in a different region of the cladding 300 emanating from the first neutral axis 230). Typically, core fiber 137 ₂ To 137 ₄ (excluding the central core fiber 137) ₁ ) May be located in different regions within the cross-sectional area 305 of the cladding 300 to provide sufficient spacing to enable propagation through the coreFiber 137 ₂ To 137 ₄ And the wavelength variation of the incident light reflected back to the console for analysis, 3D sensing of the multi-core fiber 135.

For example, where cladding 300 is characterized by a circular cross-sectional area 305 as shown in FIG. 3B, core fiber 137 ₂ To 137 ₄ May be located substantially equidistant from each other as measured along the perimeter of the cladding 300, such as at the "top" (12 o ' clock), "bottom left" (8 o ' clock), and "bottom right" (4 o ' clock) positions shown. Thus, in summary, the core fiber 137 ₂ To 137 ₄ May be located in different sections of the cross-sectional area 305. Where the cross-sectional area 305 of cladding 300 has a distal tip 330 and is characterized by a polygonal cross-sectional shape (e.g., triangular, square, rectangular, pentagonal, hexagonal, octagonal, etc.), central optical fiber 137 ₁ May be located at or near the center of the polygonal shape with the remaining core fibers 137 ₂ To 137 _M May be located near the corners between the intersecting sides of the polygonal shape.

Still referring to fig. 3A-3B, the braided tubing 310, operating as a conductive medium for the stylet 120, provides mechanical integrity to the multi-core optical fiber 135 and operates as a conductive path for electrical signals. For example, the braided tubing 310 may be exposed at the distal tip of the stylet 120. The cladding 300 and the braided tubing 310 (which is concentrically positioned around the circumference of the cladding 300) are contained within the same insulating layer 350. As shown, insulating layer 350 may be a sheath or catheter made of a protective insulating (e.g., non-conductive) material that encapsulates both cladding 300 and braided tube 310.

Referring to fig. 4A, a second exemplary embodiment of the stylet of fig. 1A is shown, according to some embodiments. Referring now to fig. 4A, a second exemplary embodiment of the stylet 120 of fig. 1A is shown that supports both optical and electrical signaling. Here, the stylet 120 is characterized by the multi-core fiber 135 described above and shown in FIG. 3A, which includes a cladding 300 and a plurality of lumens 320 located in correspondence thereto ₁ To 320 _M Inner first plurality of core fibers 137 ₁ To 137 _M (M.gtoreq.3; for embodiments, M = 4). To discloseIn the embodiment of the document, the multicore fiber 135 includes a first lumen 320 formed along the first neutral axis 230 ₁ Inner central core fiber 137 ₁ And corresponding lumens 320 located in different sections positioned within the cross-sectional area 305 of the cladding 300 ₂ To 320 ₄ Inner second plurality of core fibers 137 ₂ To 137 ₄ . Here, the multicore fibers 135 are encapsulated within the conductive tubing 400. The conductive tubing 400 may feature a "hollow" conductive cylindrical member that concentrically encapsulates the multicore fiber 135.

Referring to fig. 4A-4B, operating as a conductive medium of the stylet 120 in the transmission of electrical signals (e.g., ECG signals) to the console, the conductive tubing 400 may be exposed up to the tip 410 of the stylet 120. For this embodiment of the disclosure, a conductive epoxy 420 (e.g., a metal-based epoxy, such as a silver epoxy) may be attached to the tip 410 and similarly engaged with a termination/connection point created at the proximal end 430 of the stylet 120. The cladding 300 and the conductive tubing 400 (which are concentrically positioned around the circumference of the cladding 300) are contained within the same insulating layer 440. As shown, the insulating layer 440 may be a protective conduit that encapsulates both the cladding 300 and the conductive tubing 400.

Referring to fig. 5A, an elevation view of a first illustrative embodiment of a catheter including an integrated tubing, a septum diametrically disposed, and a micro-lumen formed within the tubing and the septum is shown, according to some embodiments. Here, catheter 130 includes an integral tube, a diametrically disposed septum 510, and a plurality of micro-lumens 530 ₁ To 530 ₄ For this embodiment, the micro-lumen is fabricated to be located within the wall 500 of the integrated tubing of the catheter 130 and within the septum 510. In particular, septum 510 divides the single lumen formed by inner surface 505 of wall 500 of catheter 130 into multiple lumens, i.e., two lumens 540 and 545 as shown. Here, a first lumen 540 is formed between a first arcuate portion 535 of the inner surface 505 forming the wall 500 of the conduit 130 and a first outer surface 555 of the septum 510 extending longitudinally within the conduit 130. A second lumen 545 is formed between a second arcuate portion 565 forming the inner surface 505 of the wall 500 of the conduit 130 and a second outer surface 560 of the septum 510.

According to one embodiment of the invention, the two lumens 540 and 545 have approximately the same volume. However, septum 510 need not divide the tubing into two equal lumens. For example, instead of the diaphragm 510 extending vertically (12 o 'clock to 6 o' clock) from the forward-facing cross-sectional view of the tubing, the diaphragm 510 may extend horizontally (3 o 'clock to 9 o' clock), diagonally (1 o 'clock to 7 o' clock; 10 o 'clock to 4 o' clock), or at an angle (2 o 'clock to 10 o' clock). In the latter configuration, each of the lumens 540 and 545 of the catheter 130 will have a different volume.

Relative to the plurality of micro-lumens 530 ₁ To 530 ₄ First micro lumen 530 ₁ Fabricated within the septum 510 at or near the cross-sectional center 525 of the integrated tubing. For this embodiment, three micro-lumens 530 ₂ To 530 ₄ Is fabricated to be located within the wall 500 of the conduit 130. In particular, a second micro-lumen 530 is fabricated within the wall 500 of the catheter 130, i.e., between the inner surface 505 and the outer surface 507 of the first arcuate portion 535 of the wall 500 ₂ . Similarly, third micro-lumen 530 ₃ Is also fabricated within the wall 500 of the conduit 130, i.e., between the inner surface 505 and the outer surface 507 of the second arcuate portion 555 of the wall 500. Fourth micro lumen 530 ₄ Is also fabricated within the inner surface 505 and the outer surface 507 of the wall 500 aligned with the diaphragm 510.

According to one embodiment of the disclosure, as shown in fig. 5A, a micro-lumen 530 ₂ To 530 ₄ Are positioned according to a "top left" (10 o ' clock), "top right" (2 o ' clock), and "bottom" (6 o ' clock) layout from a forward facing cross sectional view. Of course, the micro-lumen 530 ₂ To 530 ₄ Can be positioned differently so long as micro-lumen 530 ₂ To 530 ₄ Spaced apart along the circumference 520 of the conduit 130 to ensure more robust collection of fibers from the outer core 570 during installation ₂ To 570 ₄ The reflected light signal of (1). For example, two or more micro-lumens (e.g., micro-lumen 530) ₂ And 530 ₄ ) May be positioned at different quadrants along the circumference 520 of the conduit wall 500.

Referring to fig. 5B, a first illustration of the catheter of fig. 5A is shown, in accordance with some embodimentsA perspective view of an illustrative embodiment of the catheter including a core fiber mounted within a micro-lumen. According to one embodiment of the disclosure, a second plurality of micro-lumens 530 ₂ To 530 ₄ Is sized to retain the corresponding outer core fiber 570 ₂ To 570 ₄ Wherein a second plurality of micro-lumens 530 ₂ To 530 ₄ Can be determined to be just larger than the outer core fiber 570 ₂ To 570 ₄ Of (c) is measured. For example, the diameter of the individual core fiber and the micro-lumen 530 ₁ To 530 ₄ The size difference between the diameters of any of may range between 0.001 micrometers (μm) and 1000 μm. As a result, the outer core fiber 570 ₂ To 570 ₄ Will be smaller in cross-sectional area than the corresponding micro-lumen 530 ₂ To 530 ₄ Cross-sectional area of (a). "larger" micro-lumen (e.g., micro-lumen 530) ₂ ) Can be better applied to the outer core fiber 570 ₂ Is separate from the strain applied directly to the catheter 130 itself. Similarly, first micro-lumen 530 ₁ May be sized to retain the central core fiber 570 ₁ Wherein a first micro-lumen 530 ₁ May be sized just larger than the central core fiber 570 ₁ Of (c) is measured.

As an alternative embodiment of the disclosure, micro-lumen 530 ₁ To 530 ₄ Is sized to have a diameter exceeding the corresponding one or more core fibers 570 ₁ To 570 ₄ Of (c) is measured. However, micro-lumen 530 ₁ To 530 ₄ Is sized to fixedly retain its corresponding core fiber (e.g., the core fiber is retained without a space between its side surface and the inner wall surface of its corresponding micro-lumen). As yet another alternative embodiment of the disclosure, all of the microcavities 530 ₁ To 530 ₄ Is sized to have a diameter to fixedly retain the core fiber 570 ₁ To 570 ₄ 。

Referring to fig. 6A-6B, a flow diagram of a method of operation implemented by the medical instrument monitoring system of fig. 1A-1B to implement optical 3D shape sensing is shown, according to some embodiments. Here, the catheter includes at least one septum spanning a diameter of the tubing wall and extending longitudinally to demarcate the tubing wall. The middle (medial) portion of the septum is fabricated with a first micro-lumen, wherein the first micro-lumen is coaxial with the central axis of the catheter tubing. The first micro-lumen is configured to retain a central core fiber. Two or more of the micro-lumens other than the first micro-lumen are positioned at different locations circumferentially spaced apart along the wall of the catheter tubing. For example, two or more of the second plurality of micro-lumens may be positioned at different quadrants along the circumference of the catheter wall.

Further, each core fiber includes a plurality of sensors spatially distributed along its length between at least the proximal and distal ends of the catheter tubing. The sensor array is distributed to position the sensors at different regions of the core fiber to enable distributed measurement of strain throughout the entire length or selected portions of the catheter tubing. This distributed measurement may be transmitted by reflected light of different spectral widths (e.g., a particular wavelength or a particular range of wavelengths) that experiences certain wavelength shifts based on the type and degree of strain.

According to one embodiment of the disclosure, for each core fiber, a broadband of incident light is provided to propagate through the particular core fiber, as shown in fig. 6A (block 600). Unless exiting (discharged), when the incident light reaches the sensors of the distributed sensor array that measure the strain on a particular core fiber, the specified spectral width of light associated with the first sensor will be reflected back to the optical receiver within the console (blocks 605-610). Here, the sensor changes a characteristic of the reflected light signal to identify the type and degree of strain on the particular core fiber measured by the first sensor (blocks 615-620). According to one embodiment of the disclosure, a change in a characteristic of the reflected light signal may represent a change (offset) in the wavelength of the reflected light signal relative to the wavelength of the incident light signal associated with the specified spectral width. The sensor returns a reflected light signal through the core fiber and the remaining spectrum of incident light continues to propagate through the core fiber toward the distal end of the catheter tubing (blocks 625-630). The remaining spectrum of incident light may encounter other sensors of the distributed sensor array, where each of these sensors will operate as set forth in blocks 605-630 until the last sensor of the distributed sensor array returns a reflected light signal associated with its specified spectral width and the remaining spectrum is emitted as illumination.

Referring now to fig. 6B, during operation, a plurality of reflected optical signals are returned to the console from each of a plurality of core fibers located within a corresponding plurality of microcavities formed within a catheter (such as the catheter of fig. 1B). Specifically, the optical receiver receives the reflected optical signals from the distributed sensor array located on the central core fiber and the outer core fiber and converts the reflected optical signals into reflection data, i.e., electrical signals representing the reflected optical signals, including strain-induced wavelength shifts (blocks 650 through 655). The reflection data classification logic is configured to identify which core fibers are associated with which reflection data and to partition the reflection data provided from the reflected light signals associated with a particular measurement region (or similar spectral width) into analysis groups (blocks 660-665).

The reflection data for each analysis group is provided to shape sensing logic for analysis (block 670). Here, the shape sensing logic compares the wavelength shift at each outer core fiber to the wavelength shift at the center core fiber positioned along the center axis and operating as the neutral axis of bending (block 675). From these analyses, for all analysis groups (e.g., reflected light signals from sensors in all or most of the core fibers), the shape sensing logic may determine the shape assumed by the core fiber in 3D space, whereby the shape sensing logic may determine the current physical state of the catheter in three-dimensional space (blocks 680-685).

Referring to fig. 7A, an exemplary embodiment of the medical device monitoring system of fig. 1B during catheter manipulation and insertion into a patient is shown, according to some embodiments. In this context, the catheter 130 generally comprises an integral tube of the catheter 130 having a proximal portion 721 that generally remains outside the patient 700 and a distal portion 722 that generally resides within the vasculature of the patient after placement is complete. The (integrated) catheter tube of the catheter 130 may be advanced to a desired location within the patient's vasculature such that the distal end (or tip) 734 of the catheter tube of the catheter 130 is proximate the patient's heart, e.g., in the lower third (1/3) portion of the superior vena cava ("SVC"). In some embodiments, various instruments may be disposed at the distal end 734 of catheter 130 to measure blood pressure in specific heart chambers and vessels, to observe the interior of vessels, and the like. In alternative embodiments, such an instrument may be disposed at the distal end of the stylet 120, for example, embodiments utilizing the stylet assembly and catheter 121 of fig. 1A.

During advancement through the patient vasculature, the catheter tube of the catheter 130 receives broadband incident light 155 from the console 110 via the optical fiber 147 within the interconnect 145, wherein the incident light 155 propagates along the core fiber 137 of the multi-core optical fiber 135 within the catheter tube of the catheter 130. According to one embodiment of the present disclosure, a connector 146 that terminates an interconnection 145 of optical fibers 147 may be coupled to an optical-based catheter connector 144, which may be configured to terminate a core fiber 137 deployed within the catheter 130. This coupling optically connects the core fiber 137 of the catheter 130 with the optical fiber 147 within the interconnect 145. Optical connectivity is required to propagate the incident light 155 to the core fiber 137 and return the reflected light signal 150 through the interconnect 145 to optical logic 180 within the console 110. As described in detail below, the physical state of catheter 130 may be determined based on an analysis of the wavelength shift of reflected light signal 150, wherein the physical state includes 3D shape 735 of optical fiber 135.

In some embodiments, the system 100 may include a guide 730 having a straight section 731. The guide 730 may be formed by an introducer having a lumen through which the catheter 130 is inserted. In use, the distal portion of the guide 730 may be disposed within the patient 700 while the proximal portion remains outside the patient 700.

In some embodiments, the guide 730 (or more specifically the straight segment 731) may facilitate calibration of the optical fiber 135. For example, when the segment 733 of the optical fiber 135 is disposed within the straight segment 731, the shape framing logic 195 may interpret shape data related to the shape 733A of the segment 733 as defining a straight line.

The shape framing logic 195 may define a reference plane 750 from one or more portions of the 3D shape 735, and the reference plane 750 may define a reference frame 751 for displaying an image of the 3D shape 735. For example, according to one embodiment, curved section 740 of fiber 135/catheter 130 may define reference plane 750. In other words, the shape framing logic 195 may process the shape of the curved segment 740 to define a plane estimated by the curved segment 740. For example, the catheter 130 may be a Peripherally Inserted Central Catheter (PICC) that is positioned along the curved transition between the basilic vein 704 and the subclavian vein 705 when the PICC is inserted. As such, the shape framing logic 195 may identify the curved transition between the basilic vein 704 and the subclavian vein 705 as a curved segment 740.

According to an alternative embodiment, shape framing logic 195 may define reference plane 750 from three or more points (e.g., 741A, 741B, and 741C) arranged along 3D shape 735. In some embodiments, three points 741A, 741B, 741C may be predefined along 3D shape 735, e.g., a proximal point, a center point, and a distal point. In other embodiments, the clinician may select three points on the image of the 3D shape 735 via an input device (e.g., a computer mouse). In other embodiments, the shape framing logic 195 may automatically identify three points associated with the curved segment 740. In some embodiments, reference plane 750 may be defined such that three points 741A, 741B, 741C are equidistant from reference plane 750. As one of ordinary skill will appreciate, other geometric techniques may be utilized to define the plane 750.

With further reference to fig. 7A, the catheter 130 is shown in accordance with a front view of the patient 700. As such, the illustrated 3D shape 735 may be an elevation view of the 3D shape 735 that is consistent with an elevation view of the patient 700. In some cases, the reference plane 750 may be substantially parallel to the front of the patient 700. Accordingly, a front view of the 3D shape 735 may substantially conform to viewing the 3D shape 735 at an angle perpendicular to the reference plane 750.

Fig. 7B illustrates a 3D shape 735 that may be oriented relative to a frame of reference, according to some embodiments. The shape framing logic 195 may define a reference frame 751 for viewing an image of the 3D shape 735 on the display 170. For example, the reference frame 751 may define various views (e.g., front view, top view, right side view, etc.) of the 3D shape 735. For purposes of illustration, the reference frame 751 is shown in terms of a 3D coordinate axis system 752 having a horizontal x-axis 752A pointing to the right, a vertical y-axis 752B pointing upward, and a z-axis 752C pointing into the page. The 3D shape 735 is shown with a reference plane 750. In the illustrated embodiment, reference plane 750 is oriented with respect to reference frame 751 such that reference plane 750 is parallel to the x-y plane. Thus, a front view of the 3D shape 735 is defined by a viewing angle in the direction of the z-axis 752C, a bottom view of the 3D shape 735 is defined by a viewing angle in the direction of the y-axis 752B, and a left side view is defined by a viewing angle in the direction of the x-axis 752A. Similarly, a back view of the 3D shape 735 is defined by a viewing angle in the opposite direction of the z-axis 752C, a top view of the 3D shape 735 is defined by a viewing angle in the opposite direction of the y-axis 752B, and a right side view is defined by a viewing angle in the opposite direction of the x-axis 752A.

Shape framing logic 195 is configured to render an image of 3D shape 735 from any of the perspectives described above. The shape framing logic 195 may also facilitate rendering images of the 3D shape 735 at any angle relative to the reference frame 751, as defined by an operator via an input device. In other words, the clinician may manipulate the orientation of the 3D shape 735 to view the image 3D shape 735 from any angle. In some embodiments, the shape framing logic 195 may fix the orientation of the 3D shape 735 and/or the reference plane 750 relative to the reference frame 751.

Fig. 8 illustrates an exemplary screenshot 800 showing an image of the 3D shape 735 of fig. 7A, 7B rendered from a reference frame 751. In some embodiments, the screenshot 800 may include a representation 801 of a patient's body. For example, in the illustrated embodiment, representation 801 includes contours of a typical patient's body that may be viewed from the front to indicate the orientation of 3D shape 735. In some embodiments, representation 801 may include representations of other body parts, such as the illustrated heart. In other embodiments, the screenshot 800 may include a marker 802 to indicate the orientation of the 3D shape 735 defined by the reference frame 751 (e.g., a coordinate axis system). The image of the 3D shape 735 is not limited to a front view as shown in fig. 8. Although not shown, the shape framing logic 195 may facilitate presenting an image of the 3D shape 735 in any orientation via input from a clinician. In such embodiments, the representation 801 and/or the marker 802 may provide an indication to the clinician as to the direction of presentation of the 3D shape 735.

In some embodiments, system 100 may be communicatively coupled with an imaging system (e.g., ultrasound, MRI, X-ray, etc., not shown) and shape framing logic 195 may facilitate presenting images of 3D shape 735 as well as images of the patient. In some cases, a clinician may orient and/or position an image of the 3D shape 735 to position a portion of the 3D shape 735 (e.g., a catheter tip) at a particular location relative to a patient image. Since the imaging system may directly include an image of the medical device, such an image may facilitate a visual comparison between the 3D shape 735 and the image of the medical device.

In further embodiments, other device positions or tracking modalities may be coupled with the system 100 and used to indicate the position of the catheter 130. Such modalities may include ECG signal monitoring and magnetic field sensing as described above, for example, as described in U.S. patent No. 5,099,845, entitled "Medical Instrument Location Means," the entire contents of which are incorporated herein by reference. In this way, the system 100 may present images or information related to device location or tracking data on the display 170 in conjunction with the image of the 3D shape 735.

Referring to fig. 9, a flow diagram of a method operations performed by the medical instrument monitoring system of fig. 1A-1B to present an image of a 3D shape 735 on a display is shown, according to some embodiments. The method 900 may be performed by the shape framing logic 195. In other embodiments, the shape framing logic 195 may be incorporated into the shape sensing logic 194, and as such, the method 900 may be performed by the shape sensing logic 194. The method 900 generally processes shape data to render an image of a 3D shape on a display. According to one embodiment of the present disclosure, as shown in fig. 9, shape framing logic 195 receives 3D shape data relating to the 3D shape of the catheter from shape sensing logic 194 (block 910).

The shape framing logic 195 then identifies a portion of the 3D shape for defining a reference plane (block 920). The identifying may include comparing the portion of the 3D shape to one or more predefined shapes in memory. The predefined shape in the memory may be associated with a shape of the anatomical element in the patient at its known location. In some embodiments, the predefined shapes in memory may be established according to boundary conditions based on typical anatomical structures in the population.

For example, the predefined shape in memory may include a curved portion, and the shape framing logic 195 searches the 3D shape to identify a portion of the 3D shape that is consistent with the curved shape in memory. As a result of identifying a portion of the 3D shape that conforms to the curved shape in memory, the shape framing logic 915 may select three or more points along the identified portion of the 3D shape to define the reference plane. According to one embodiment, the predefined shape in the memory may conform to a curve of a 3D shape defined by a vasculature of a patient (e.g., a vasculature extending between a basilic vein and a subclavian vein).

In some embodiments, the system may include a plurality of curved shapes in memory associated with a plurality of medical procedures. In such embodiments, the shape framing logic 195 may receive input from the clinician relating to the medical procedure, including the insertion site of the medical device. The input from the clinician may include (i) the location of the insertion site of the medical device, including the right and left sides of the patient, (ii) the type of medical device (e.g., central venous catheter, infusion port, or PICC), (iii) the orientation of the patient, or (iv) the orientation of a body part (e.g., arm). The shape framing logic 195 may select a curved shape from the plurality of curved shapes in memory based on input from the clinician and compare the curved portion of the 3D shape to the selected curved shape.

The shape framing logic 195 may then define a frame of reference for the 3D image from the identified portion of the 3D shape (block 930). According to one embodiment, the shape framing logic 195 may initially define a plane according to the identified portions described above with respect to (block 920). As one of ordinary skill will appreciate, the plane may be defined according to various geometric techniques, such as three points, a line and a point, or a line and a direction. For example, the shape framing logic 195 may define a reference plane from three points arranged along the identified portion of the 3D shape and then define a reference frame that indicates the direction of the 3D shape (e.g., front to back, top to bottom, left to right). In some cases, the reference frame may be defined such that the front side of the reference frame is parallel to the plane.

The shape framing logic 195 may then define an image of the 3D shape according to the frame of reference (block 940). In other words, the shape framing logic 195 may define an image of the 3D shape that may be viewed on the display from one or more viewpoints relative to the reference frame, i.e., from the front, top, right, etc. In some embodiments, the shape framing logic 195 may define an image of the 3D shape that is visible from any direction relative to the reference frame. The shape framing logic 195 may then render an image of the 3D shape on the display (block 950).

Fig. 10 illustrates an embodiment of a reference guide 1030 for defining a reference plane for a 3D shape 1035, which may be defined by shape sensing logic 194 in a manner similar to the 3D shape 735 of fig. 7A and 7B. Reference guide 1030 is configured to define a plane 1050 and an outcome reference frame 1051. In the illustrated embodiment, the reference guide 1030 includes a plate 1031 that defines a plane. The plate 1031 includes a recess 1032 disposed along a top surface of the plate 1031 that defines the rail, and the recess 1032 is configured to receive a segment of the conduit 130. A proximal portion 1021 of the catheter 130 disposed outside the patient 700 is placed within the groove 1032 to define a curved section 1040 (i.e., the optical fiber 135) of the catheter 130.

Similar to the curved segment 740 of fig. 7A, the curved segment 1040 may define a plane 1050. In other words, the shape framing logic 195 may process the shape data of the curved segment 1040 to define the plane 1050 geometrically estimated by the curved segment 1040. With reference plane 1050 defined, shape framing logic 195 may then define a reference frame 1051, which may be similar in some respects to reference frame 751 of fig. 7A and 7B, for viewing an image of 3D shape 1035 on display 170. In the illustrated embodiment, the plane 1050 is parallel to the plate 1031 when the curved segments 1040 are disposed within the recesses 1032. The form of reference guide 1040 is not limited to a flat plate, i.e., reference guide 1030 may take any form suitable for defining curved shape 1040.

In use, a clinician inserts catheter 130 into patient 700. The clinician places the proximal portion 1021 of the catheter 130 with the groove 1032 to define a curved section 1040. Shape sensing logic 194 determines 3D shape 1035 of conduit 130 and shape framing logic 195 determines plane 1050 from curved segment 1040 (i.e., the portion of 3D shape 1035 extending along curved segment 1040). Shape framing logic 195 defines a reference frame 1051 according to plane 1050 and renders an image of 3D shape 1035 on display 170.

The clinician may orient the reference frame 1051 via the orientation of the reference guide 1030. Since the reference guide 1030 and associated curved segment 1040 are disposed outside the patient 700, the clinician may orient the reference guide 1030 to define the viewpoint of the 3D shape 1035. For example, the clinician may orient reference guide 1030 parallel to the anterior side of patient 700 to define a front view of 3D shape 1035. In short, the clinician may orient the reference guide 1030 by adjusting the orientation of the reference guide 1030 to facilitate viewing of the image of the 3D shape 1035 on the display 170 from any angle.

Although certain specific embodiments have been disclosed herein, and specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and/or modifications may occur to those skilled in the art, and are intended to be included within the broader aspects. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims (30)

1. A medical device system, comprising:

a medical device comprising an optical fiber having one or more core fibers, each of the one or more core fibers comprising a plurality of sensors distributed along a longitudinal length of the respective core fiber, each sensor of the plurality of sensors configured to:

(i) Reflects optical signals of different spectral widths based on the received incident light, an

(ii) Changing a characteristic of the reflected optical signal based on the strain experienced by the optical fiber; and

a console comprising one or more processors and a non-transitory computer-readable medium having logic stored thereon that, when executed by the one or more processors, causes operations comprising:

providing an incident optical signal to the optical fiber;

receiving reflected light signals of different spectral widths of the incident light reflected by one or more of the plurality of sensors;

processing reflected light signals associated with the one or more core fibers to determine a three-dimensional shape of the optical fiber;

defining a reference frame for displaying an image of a three-dimensional shape;

orienting the three-dimensional shape within the reference frame; and

rendering an image of the three-dimensional shape on a display of the system according to the reference frame.

2. The system of claim 1, wherein orienting the three-dimensional shape comprises:

defining a reference plane from a portion of the three-dimensional shape;

fixing the three-dimensional shape to the reference plane; and

orienting the reference plane relative to the frame of reference.

3. The system of claim 2, wherein:

the portion of the three-dimensional shape includes three or more points arranged along the three-dimensional shape, an

The three or more points are equidistant from the reference plane.

4. The system of claim 1, further comprising:

a guide comprising a lumen extending along a linear portion of the guide, wherein:

in use, the optical fiber is inserted into the lumen, and

the operations further include calibrating the optical fiber according to the straight portion.

5. The system of claim 2, wherein the operations further comprise: orienting the reference plane relative to the frame of reference such that an elevation image of the three-dimensional shape according to the reference plane is aligned with an elevation according to the frame of reference.

6. The system of claim 2, wherein the operations further comprise fixing the reference plane relative to the frame of reference.

7. The system of claim 2, wherein the operations further comprise:

comparing the curved portion of the three-dimensional shape to a curved shape stored in memory; and

as a result of the comparison, when the curved portion of the three-dimensional shape conforms to the curved shape stored in memory, three or more points are identified from the curved portion to define the reference plane.

8. The system of claim 7, wherein, in use, the curved portion of the three-dimensional shape is disposed along a basilic vein, a subclavian vein, a innominate vein, or a superior vena cava of a patient.

9. The system of claim 7, further comprising:

a plurality of curved shapes stored in a memory, the plurality of curved shapes associated with a plurality of different insertion sites of the medical device, wherein the operations further comprise:

receiving an input from a clinician, the input defining an insertion site for the medical device;

selecting a curved shape from the plurality of curved shapes, the selected curved shape associated with a defined insertion site; and

comparing the curved portion of the three-dimensional shape to a selected curved shape.

10. The system of claim 9, wherein the input further defines the insertion site as being located on a right side or a left side of the patient.

11. The system of claim 7, further comprising a reference guide coupled with the medical device, wherein the curved portion of the three-dimensional shape is disposed along a path of the reference guide.

12. The system of claim 11, wherein an orientation of the reference guide relative to the patient defines an orientation of the three-dimensional shape relative to the patient.

13. The system of claim 12, wherein, in use, the reference guide is displaced relative to the patient between a first guide orientation and a second guide orientation to move the three-dimensional shape relative to the patient between a first three-dimensional shape orientation and a second three-dimensional shape orientation.

14. The system of claim 1, wherein:

the system is coupled to a patient imaging system, and

the operations further include:

receiving image data from the patient imaging system; and

presenting an image of a patient and an image of the three-dimensional shape on the display.

15. The system of claim 1, wherein the medical device is one of an introducer wire, a guidewire, a stylet within a needle, a needle having optical fibers embedded in a cannula of a needle, or a catheter having optical fibers embedded in one or more walls of a catheter.

16. A method for detecting placement of a medical device within a patient, the method comprising:

providing an incident optical signal to an optical fiber included within the medical device, wherein the optical fiber includes one or more core fibers, each of the one or more core fibers includes a plurality of reflection gratings distributed along a longitudinal length of the respective core fiber, and each of the plurality of reflection gratings is configured to: (i) Reflecting optical signals of different spectral widths based on the received incident light; and (ii) altering a characteristic of the reflected optical signal based on the strain experienced by the optical fiber;

receiving reflected light signals of different spectral widths of incident light reflected by one or more of the plurality of sensors;

processing reflected light signals associated with the one or more core fibers to determine a three-dimensional shape of the optical fiber;

defining a frame of reference for displaying an image of the three-dimensional shape;

orienting the three-dimensional shape within the reference frame; and

rendering an image of the three-dimensional shape on a display of a system according to the reference frame.

17. The method of claim 16, wherein orienting the three-dimensional shape comprises:

defining a reference plane from a portion of the three-dimensional shape;

fixing the three-dimensional shape to the reference plane; and

the reference plane is oriented relative to the reference frame.

18. The method of claim 17, wherein:

the portion of the three-dimensional shape includes three or more points arranged along the three-dimensional shape, and

the three or more points are equidistant from the reference plane.

19. The method of claim 16, wherein:

the system includes a guide having a lumen extending along a linear portion of the guide,

in use, the optical fibre is inserted into the lumen, and

the method also includes calibrating the optical fiber according to the straight portion.

20. The method of claim 19, further comprising inserting the guide into the patient.

21. The method of claim 17, further comprising:

orienting the reference plane relative to the frame of reference such that an elevation image of the three-dimensional shape according to the reference plane is aligned with an elevation according to the frame of reference.

22. The method of claim 17, further comprising fixing the reference plane relative to the frame of reference.

23. The method of claim 17, further comprising:

comparing the curved portion of the three-dimensional shape to a curved shape stored in a memory of the system; and

as a result of the comparison, when the curved portion of the three-dimensional shape conforms to the curved shape stored in memory, three or more points are identified from the curved portion to define the reference plane.

24. The method of claim 23, wherein, in use, the curved portion of the three-dimensional shape is disposed along a basilic vein, a subclavian vein, a innominate vein, or a superior vena cava of the patient.

25. The method of claim 23, wherein the system comprises a plurality of curved shapes stored in memory, the plurality of curved shapes being associated with a plurality of different insertion sites, wherein the method further comprises:

receiving an input from a clinician, the input defining an insertion site of the medical device;

selecting a curved shape from the plurality of curved shapes, the selected curved shape associated with a defined insertion site; and

comparing the curved portion of the three-dimensional shape to a selected curved shape.

26. The method of claim 25, wherein the input further positions the insertion site to be on the right or left side of the patient.

27. The method of claim 23, wherein:

the system further includes a reference guide coupled with the medical device, and

the curved portion of the three-dimensional shape is arranged along a path of the reference guide.

28. The method of claim 27, wherein the orientation of the reference guide relative to the patient defines an orientation of the three-dimensional shape relative to the patient.

29. The method of claim 28, further comprising:

displacing the reference guide relative to the patient between a first guide orientation and a second guide orientation to move the three-dimensional shape relative to the patient between a first three-dimensional shape orientation and a second three-dimensional shape orientation.

30. The method of claim 16, wherein the system is coupled to a patient imaging system, the method further comprising:

receiving image data from the patient imaging system, and

presenting an image of the patient and an image of the three-dimensional shape on the display.

Images